Top

Gepubliceerd in:

26-03-2021

Translation and psychometric validation of the traditional Chinese version of patient-reported outcomes measurement information system Pediatric-25 Profile version 2.0 (PROMIS-25) in Chinese Children with Cancer in Hong Kong

Auteurs: Stephen W. W. Chan, C. W. Chien, Arnold Y. L. Wong, Marco Y. C. Pang

Gepubliceerd in: Quality of Life Research | Uitgave 6/2021

Abstract

Purpose

To translate and cross-cultural validate the PROMIS Pediatric-25 Profile 2.0 (PROMIS-25) into traditional Chinese, and to investigate its psychometric properties in children with cancer in Hong Kong.

Methods

The Functional Assessment of Chronic Illness Therapy translation methodology was adopted in this study. Three panel members evaluated the semantic equivalence and content validity. The psychometric properties were tested with 103 children with cancer (10–18 years). Internal consistency and structural validity were examined by Cronbach’s alpha and Rasch analysis. Convergent and divergent validity were assessed by correlating it with traditional Chinese pediatric quality of life inventory™ 4.0 domains (traditional Chinese PedsQL™ 4.0), traditional Chinese Health Questionnaire-9 (C-PHQ-9), and the numeric pain rating scale (NPRS).

Results

The semantic equivalence score and content validity index were both 100%. All domains indicated good internal consistency (α = 0.83–0.88) and unidimensionality (variance explained > 55.5% and 1st contrast eigenvalues < 2.0). All items showed good item fit (0.6–1.4). For convergent validity, the traditional Chinese PROMIS-25 domains demonstrated moderate-to-large correlations with traditional Chinese PedsQL™ 4.0 domains (r ≥ ± 0.69), C-PHQ-9 Item-4 and total score (r = 0.75–0.80), except NPRS (r = 0.44). For divergent validity, traditional Chinese PROMIS-25 had low correlations with traditional Chinese PedsQL™ 4.0 domains (r < ± 0.21), C-PHQ-9 item-4 (r = 0.3), and NPRS (r = − 0.12). The traditional Chinese PROMIS-25 fatigue domain was weakly correlated with NPRS (r = 0.39).

Conclusion

The traditional Chinese PROMIS-25 is semantically and conceptually like the original PROMIS-25 with satisfactory internal consistency, structural validity, and construct validity.

vorige artikel Adverse childhood experiences and impact on quality of life in adulthood: development and validation of a short difficult childhood questionnaire in a large population-based health survey

volgende artikel Cross‑cultural adaptation, construct validity, reliability, and responsiveness of the Thai version of the Patient-Rated Wrist/Hand Evaluation (Thai PRWHE)

Steliarova-Foucher, E., Colombet, M., Ries, L. A., Moreno, F., Dolya, A., Bray, F., et al. (2017). International incidence of childhood cancer, 2001–10: A population-based registry study. The Lancet Oncology, 18(6), 719–731.PubMedPubMedCentral

Hospital Authority. Top Five Cancers by Age. Hong Kong Cancer Registry. URL: http://www3.ha.org.hk/cancereg/default.asp. Accessed Mar 8 2020.

McCabe, M. (2009). Fatigue in children with long-term conditions: An evolutionary concept analysis. Journal of Advanced Nursing, 65(8), 1735–1745. https://doi.org/10.1111/j.1365-2648.2009.05046.x.CrossRefPubMed

Hudson, M. M., Mertens, A. C., Yasui, Y., Hobbie, W., Chen, H., Gurney, J. G., et al. (2003). Health status of adult long-term survivors of childhood cancer: A report from the Childhood Cancer Survivor Study. JAMA, 290(12), 1583–1592. https://doi.org/10.1001/jama.290.12.1583.CrossRefPubMed

U.S. Food & Drug Administration. Patient-reported outcome measures: use in medical product development to support labelling claims. URL: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims. Accessed Mar 25 2021.

Mercieca-Bebber, R., King, M. T., Calvert, M. J., Stockler, M. R., & Friedlander, M. J. P. R. O. M. (2018). The importance of patient-reported outcomes in clinical trials and strategies for future optimization. Patient Related Outcome Measures, 9, 353.PubMedPubMedCentral

Au, H.-J., Ringash, J., Brundage, M., Palmer, M., Richardson, H., Meyer, R. M. J. E. R. O. P., et al. (2010). Added value of health-related quality of life measurement in cancer clinical trials: The experience of the NCIC CTG. Expert Review of Pharmacoeconomics & Outcomes Research, 10(2), 119–128.

Bottomley, A., Pe, M., Sloan, J., Basch, E., Bonnetain, F., Calvert, M., et al. (2016). Analysing data from patient-reported outcome and quality of life endpoints for cancer clinical trials: A start in setting international standards. Lancet Oncology, 17(11), e510–e514.PubMed

DeWalt, D. A., Rothrock, N., Yount, S., & Stone, A. A. (2007). Evaluation of item candidates: The PROMIS qualitative item review. Medical Care, 45(5 Suppl 1), S12.PubMedPubMedCentral

10.

Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., Dewitt, E. M., Lai, J. S., et al. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Quality of Life Research, 19(4), 595–607. https://doi.org/10.1007/s11136-010-9619-3.CrossRefPubMedPubMedCentral

11.

Lai, J. S., Stucky, B. D., Thissen, D., Varni, J. W., DeWitt, E. M., Irwin, D. E., et al. (2013). Development and psychometric properties of the PROMIS((R)) pediatric fatigue item banks. Quality of Life Research, 22(9), 2417–2427. https://doi.org/10.1007/s11136-013-0357-1.CrossRefPubMed

12.

Varni, J. W., Stucky, B. D., Thissen, D., Dewitt, E. M., Irwin, D. E., Lai, J. S., et al. (2010). PROMIS Pediatric Pain Interference Scale: An item response theory analysis of the pediatric pain item bank. Journal of Pain, 11(11), 1109–1119. https://doi.org/10.1016/j.jpain.2010.02.005.CrossRef

13.

Dewalt, D. A., Thissen, D., Stucky, B. D., Langer, M. M., Morgan Dewitt, E., Irwin, D. E., et al. (2013). PROMIS Pediatric Peer Relationships Scale: Development of a peer relationships item bank as part of social health measurement. Health Psychology, 32(10), 1093–1103. https://doi.org/10.1037/a0032670.CrossRefPubMed

14.

DeWitt, E. M., Stucky, B. D., Thissen, D., Irwin, D. E., Langer, M., Varni, J. W., et al. (2011). Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: Built using item response theory. Journal of Clinical Epidemiology, 64(7), 794–804. https://doi.org/10.1016/j.jclinepi.2010.10.012.CrossRefPubMedPubMedCentral

15.

Lee, S., Cheung, Y., Wong, H., Leung, T., Lam, T., & Lau, Y. J. B. O. (2013). Chronic health problems and health-related quality of life in Chinese children and adolescents: a population-based study in Hong Kong. BMJ Open, 3(1), 1183.

16.

Yeung, N. C., Lau, J. T., Yu, X.-N., Chu, Y., Shing, M. M., Leung, T. F., et al. (2013). Psychometric properties of the Chinese version of the pediatric quality of life inventory 4.0 Generic core scales among pediatric cancer patients. Cancer Nursing, 36(6), 463–473.PubMed

17.

Patient-reported Outcome Measurment Information System. PROMIS Pediatric and Parent Proxy Profile Instruments [Internet]. (2017). https://www.assessmentcenter.net/documents/PROMIS%20Pediatric%20Profile%20Scoring%20Manual.pdf. Accessed Jan 16 2020.

18.

Liu, Y., Yuan, C., Wang, J., Shen, N., Shen, M., & Hinds, P. S. J. C. N. (2019). Chinese version of pediatric patient-reported outcomes measurement information system short form measures: Reliability, validity, and factorial structure assessment in children with cancer in China. Cancer Nursing, 42(6), 430–438.PubMed

19.

Liu, Y., Hinds, P. S., Wang, J., Correia, H., Du, S., Ding, J., et al. (2013). Translation and linguistic validation of the pediatric patient-reported outcomes measurement information system measures into simplified Chinese using cognitive interviewing methodology. Cancer Nursing, 36(5), 368–376.PubMed

20.

Eremenco, S. L., Cella, D., & Arnold, B. J. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions, 28(2), 212–232.

21.

Bujang, M. A., & Baharum, N. J. W. (2016). Sample size guideline for correlation analysis. World Journal of Social Science Research, 3(1), 37.

22.

Reeve, B. B., McFatrich, M., Mack, J. W., Pinheiro, L. C., Jacobs, S. S., Baker, J. N., et al. (2020). Expanding construct validity of established and new PROMIS Pediatric measures for children and adolescents receiving cancer treatment. Pediatric Blood & Cancer, 67(4), e28160.

23.

Chen, W.-H., Lenderking, W., Jin, Y., Wyrwich, K. W., Gelhorn, H., & Revicki, D. A. J. Q. O. L. R. (2014). Is Rasch model analysis applicable in small sample size pilot studies for assessing item characteristics? An example using PROMIS pain behavior item bank data. Quality of Life Research, 23(2), 485–493.PubMed

24.

Eremenco, S. L., Cella, D., & Arnold, B. J. J. E. (2005). A comprehensive method for the translation and cross-cultural validation of health status questionnaires. Evaluation & the Health Professions, 28(2), 212–232.

25.

Varni, J. W., Seid, M., & Kurtin, P. S. (2001). PedsQL 4.0: Reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care, 39(8), 800–812.PubMed

26.

Hao, Y., Tian, Q., Lu, Y., Chai, Y., & Rao, S. J. Q. O. L. R. (2010). Psychometric properties of the Chinese version of the Pediatric Quality of Life Inventory^TM 4.0 generic core scales. Health and Quality of Life Outcomes, 19(8), 1229–1233.

27.

Tsai, F.-J., Huang, Y.-H., Liu, H.-C., Huang, K.-Y., Huang, Y.-H., & Liu, S.-I.J.P. (2014). Patient health questionnaire for school-based depression screening among Chinese adolescents. Pediatrics, 133(2), e402–e409.PubMed

28.

Leung, D. Y., Mak, Y. W., Leung, S. F., Chiang, V. C., & Loke, A. Y. J. A. P. P. (2020). Measurement invariances of the PHQ-9 across gender and age groups in Chinese adolescents. Asia-Pacific Psychiatry, 123, 81. https://doi.org/10.1111/appy.12381.CrossRef

29.

Ho, K. Y., Li, W. H., Lam, K. W., Chui, S. Y., & Chan, C. F. (2015). Psychometric properties of the Chinese version of the fatigue scale-adolescent. BMC Cancer, 15, 938. https://doi.org/10.1186/s12885-015-1945-y.CrossRefPubMedPubMedCentral

30.

Lynn, M. R. (1986). Determination and quantification of content validity. Nursing Research, 35(6), 382–385.PubMed

31.

Polit, D. F., & Beck, C. T. (2004). Nursing research: Principles and methods. Lippincott: Williams & Wilkins.

32.

Terwee, C. B., Bot, S. D., de Boer, M. R., van der Windt, D. A., Knol, D. L., Dekker, J., et al. (2007). Quality criteria were proposed for measurement properties of health status questionnaires. Journal of Clinical Epidemiology, 60(1), 34–42.PubMed

33.

De Vet, H. C., Terwee, C. B., Mokkink, L. B., & Knol, D. L. (2011). sMeasurement in medicine: A practical guide. Cambridge: Cambridge University Press.

34.

Hu, L. T., & Bentler, P. M. (1999). Cutoff criteria for fit indexes in covariance structure analysis: Conventional criteria versus new alternatives. Structural Equation Modeling: A Multidisciplinary Journal, 6(1), 1–55.

35.

Carmines, E. G., & Zeller, R. A. (1979). Reliability and validity assessment (Vol. 17). Thousand Oaks, CA: Sage.

36.

Streiner, D. L., Norman, G. R., & Cairney, J. (2015). Health measurement scales: A practical guide to their development and use. Oxford: Oxford University Press.

37.

Tsutakawa, R. K., & Johnson, J. C. (1990). The effect of uncertainty of item parameter estimation on ability estimates. Psychometrika, 55(2), 371–390.

38.

Bond, T. G., & Fox, C. M. (2001). Applying the Rasch model: Fundamental measurement in the human sciences. East Sussex: Psychology Press.

39.

Krumlinde-Sundholm, L., Holmefur, M., Kottorp, A., Eliasson, A. C. J. D. M., & Neurology, C. (2007). The Assisting Hand Assessment: Current evidence of validity, reliability, and responsiveness to change. Developmental Medicine & Child Neurology, 49(4), 259–264.

40.

Linacre, J. M. (2011). A user’s guide to WINSTEPS Ministeps. Chicago: Rasch Model Computer Programs.

41.

Mukaka, M. J. M. M. J. (2012). Statistics corner: A guide to appropriate use of correlation in medical research. Malawi Medical Journal, 24(3), 69–71.PubMedPubMedCentral

42.

Padilla, J.-L., & Leighton, J. P. (2017). Cognitive interviewing and think aloud methods. In B. Zumbo & A. M. Hubley (Eds.), Understanding and investigating response processes in validation research (pp. 211–228). Berlin: Springer.

43.

OudeVoshaar, M. A., ten Klooster, P. M., Taal, E., Krishnan, E., & van Laar, M. A. J. A. R. (2012). Dutch translation and cross-cultural adaptation of the PROMIS® physical function item bank and cognitive pre-test in Dutch arthritis patients. Arthritis Research and Therapy, 14(2), 1–7.

44.

Irwin, D. E., Varni, J. W., Yeatts, K., DeWalt, D. A. J. H., & Outcomes, Q. O. L. (2009). Cognitive interviewing methodology in the development of a pediatric item bank: A patient reported outcomes measurement information system (PROMIS) study. Health and Quality of Life Outcomes, 7(1), 3.PubMedPubMedCentral

45.

Rebok, G., Riley, A., Forrest, C., Starfield, B., Green, B., Robertson, J., et al. (2001). Elementary school-aged children’s reports of their health: a cognitive interviewing study. Quality of Life Research, 10(1), 59–70.PubMed

46.

Westmoreland, K., Reeve, B. B., Amuquandoh, A., van der Gronde, T., Manthalu, O., Correia, H., et al. (2018). Translation, psychometric validation, and baseline results of the Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric measures to assess health-related quality of life of patients with pediatric lymphoma in Malawi. Pediatric Blood & Cancer, 65(11), e27353.

47.

DeWitt, E. M., Stucky, B. D., Thissen, D., Irwin, D. E., Langer, M., Varni, J. W., et al. (2011). Construction of the eight-item patient-reported outcomes measurement information system pediatric physical function scales: built using item response theory. Journal of Clinical Epidemiology, 64(7), 794–804.PubMedPubMedCentral

48.

Irwin, D. E., Stucky, B., Langer, M. M., Thissen, D., DeWitt, E. M., Lai, J.-S., et al. (2010). An item response analysis of the pediatric PROMIS anxiety and depressive symptoms scales. Qual Life Res, 19(4), 595–607.PubMedPubMedCentral

49.

Lai, J.-S., Stucky, B. D., Thissen, D., Varni, J. W., DeWitt, E. M., Irwin, D. E., et al. (2013). Development and psychometric properties of the PROMIS® pediatric fatigue item banks. Quality of Life Research, 22(9), 2417–2427.PubMed

50.

DeWalt, D. A., Thissen, D., Stucky, B. D., Langer, M. M., Morgan DeWitt, E., Irwin, D. E., et al. (2013). PROMIS pediatric peer relationships scale: development of a peer relationships item bank as part of social health measurement. Health Psychology, 32(10), 1093.PubMed

51.

Varni, J. W., Stucky, B. D., Thissen, D., DeWitt, E. M., Irwin, D. E., Lai, J.-S., et al. (2010). PROMIS Pediatric Pain Interference Scale: an item response theory analysis of the pediatric pain item bank. Pain, 11(11), 1109–1119.

52.

Kashikar-Zuck, S., Zafar, M., Barnett, K. A., Aylward, B. S., Strotman, D., Slater, S. K., et al. (2013). Quality of life and emotional functioning in youth with chronic migraine and juvenile fibromyalgia. The Clinical Journal of Pain, 29(12), 1066–1072.PubMed

53.

Løvaas, M. E. S., Sund, A. M., Patras, J., Martinsen, K., Hjemdal, O., Neumer, S.-P., et al. (2018). Emotion regulation and its relation to symptoms of anxiety and depression in children aged 8–12 years: Does parental gender play a differentiating role? BMC Psychology, 6(1), 42.

54.

Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001). The PHQ-9: Validity of a brief depression severity measure. Journal of General Internal Medicine, 16(9), 606–613.PubMedPubMedCentral

55.

Choi, S., Podrabsky, T., McKinney, N., Schalet, B., Cook, K., & Cella, D. J. C., IL: Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University. (2012). PROSetta Stone® analysis report: A Rosetta Stone for patient reported outcomes.

56.

Richardson, L. P., McCauley, E., Grossman, D. C., McCarty, C. A., Richards, J., Russo, J. E., et al. (2010). Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics, 126(6), 1117.PubMedPubMedCentral

57.

Hinz, A., Mehnert, A., Kocalevent, R.-D., Brähler, E., Forkmann, T., Singer, S., et al. (2016). Assessment of depression severity with the PHQ-9 in cancer patients and in the general population. BMC Psychiatry, 16(1), 22.PubMedPubMedCentral

58.

Hinds, P. S., Hockenberry-Eaton, M., Gilger, E., Kline, N., Burleson, C., Bottomley, S., et al. (1999). Comparing patient, parent, and staff descriptions of fatigue in pediatric oncology patients. Cancer Nursing, 22(4), 277–289.PubMed

59.

Kashikar-Zuck, S., Carle, A., Barnett, K., Goldschneider, K. R., Sherry, D. D., Mara, C. A., et al. (2016). Longitudinal evaluation of patient reported outcomes measurement information systems (PROMIS) measures in pediatric chronic pain. Pain, 157(2), 339.PubMedPubMedCentral

60.

Devine, K. A., Willard, V. W., Hocking, M. C., Stapleton, J. L., Rotter, D., Bukowski, W. M., et al. (2018). PROMIS peer relationships short form: How well does self-report correlate with data from peers? Journal of Pediatric Psychology, 43(9), 1059–1067.PubMedPubMedCentral

Titel: Translation and psychometric validation of the traditional Chinese version of patient-reported outcomes measurement information system Pediatric-25 Profile version 2.0 (PROMIS-25) in Chinese Children with Cancer in Hong Kong
Auteurs: Stephen W. W. Chan
C. W. Chien
Arnold Y. L. Wong
Marco Y. C. Pang
Publicatiedatum: 26-03-2021
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research / Uitgave 6/2021
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-021-02759-8

Andere artikelen Uitgave 6/2021

Health-related quality of life associated with risk of death in Brazilian dialysis patients: an eight-year cohort

Differences in mental health and health-related quality of life between the Israeli and Italian population during a COVID-19 quarantine

Patient-reported outcomes and the identification of subgroups of atrial fibrillation patients: a retrospective cohort study of linked clinical registry and administrative data

Longitudinal change of quality of life in the first five years of survival among disease-free Chinese breast cancer survivors

The validity of proxy responses on patient-reported outcome measures: Are proxies a reliable alternative to stroke patients’ self-report?

Identifying the minimal important difference in patient-reported outcome measures in the field of people with severe mental illness: a pre–post-analysis of the Illness Management and Recovery Programme

Open Access